Quality Assurance Engineer

1 week ago


Austin, Texas, United States Enovis Full time

About the Role:

We are seeking a highly skilled Quality Assurance Engineer to join our team at Enovis. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Author and review validations for an orthopedic manufacturing facility
  • Review and provide input to project plans for insourcing, new equipment, new cells, etc.
  • Support Operations to remedy adverse quality or compliance situations
  • Write and edit procedures, work instructions, and validation protocols and reports
  • Author and review change orders for manufacturing changes and assess requirements
  • Work on complex special projects as assigned

Requirements:

  • Bachelor's in Science or Engineering and 3+ years of experience
  • Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 quality standards
  • Knowledge of technical writing quality and best practices
  • Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization
  • Individual should have knowledge of Microsoft Office Suite of software or equivalent

What We Offer:

We offer a comprehensive benefits package, including medical insurance, dental insurance, vision insurance, spending and savings accounts, 401(k) plan, vacation, sick leave, and holidays, income protection plans, discounted insurance rates, and legal services.

About Enovis:

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.



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